Anyone who watched the nightly news or sports broadcasts in the last decade likely heard the pitch for testosterone replacement: The hormone can cure a sagging libido and restore youthful energy levels, promised the healthy-looking middle-aged men in the ads for products like AndroGel from
Over the last 10 years, testosterone prescriptions have risen 10-fold in the U.S. and 40-fold in Canada, according to an editorial published today in the Journal of the American Geriatrics Society. It’s likely no coincidence that the U.S. and Canada are two of only three countries (the other being New Zealand) that allow direct-to-consumer advertising of prescription drugs, say the authors, Thomas Perls, a professor at Boston University and geriatrician at Boston Medical Center, and David Handelsman, a professor at the University of Sydney in Australia.
Testosterone makers and some doctors “market the idea that men go through something similar to menopause, where they have these marked declines in testosterone and all these symptoms that we normally attribute to aging,” Perls says. “They say ‘If we give you testosterone, it will reverse the problem.’ It was a wildly successful ad campaign. We consider it to be disease mongering.”
Perls and Handelsman’s critique of testosterone marketing comes just weeks after the U.S. Food & Drug Administration issued tough new rules for the companies that market the hormone treatment. The agency demanded labels be revised make it clear the drugs are only for patients with diseases like hypogonadism or injuries that cause severely low levels of testosterone, and that replacement therapy may raise the risk of cardiovascular problems. Furthermore, the agency ordered testosterone makers to conduct post-marketing research to better elucidate testosterone's risks.
But Perls and Handelsman argue that’s not enough. They’re calling for the agency to team up with the Federal Trade Commission and ban testosterone advertising for “contrived” conditions such as Low T or “andropause,” the term commonly used for male menopause. And they’re urging the FDA and Health Canada to require physicians to demonstrate—with legitimate hormone testing and the like—that any patient handed a prescription for testosterone actually has a disease that needs to be treated.
Thomas Perls is a professor at Boston University and geriatrician at Boston Medical Center (Credit:... [+]
“Normally the FDA does not allow advertising of products for indications that they have not approved,” Perls says. “The FDA has said aging is not an indication. Well let’s take that a step further and say you can’t advertise testosterone for something called Low T. That’s not an approved indication.”
A spokesperson for Eli Lilly says in an e-mailed statement that the company is no longer airing TV ads for Axiron but that its executives believe “we can continue to play an important role in providing responsible education to consumers. Patient safety is our top priority. All of Lilly’s consumer-facing efforts, including advertising and educational information on Axiron.com, contain prominent safety information.” He adds that Lilly’s consumer-facing materials are reviewed by the FDA Office of Prescription Drug Promotion.
A spokesperson for AbbVie says in an e-mailed statement the company's "educational efforts provide valuable health information about hypogonadism....Our hypogonadism educational efforts follow the Food and Drug Administration's guidance and our brand-specific advertising adheres to the agency’s regulations.”
It isn’t just the advertising that has driven the testosterone market to new highs, Perls and Handelsman write in their editorial. They are also concerned about “lax” professional guidelines for prescribing the hormone that they say stretch the definition of hypogonadism. Some guidelines from medical organizations suggest that men whose blood tests indicate low levels of the hormone—and who cite common complaints of aging such as low energy and insomnia—may be candidates for testosterone, even if they don’t fit the classical definition of hypogonadism, the authors say.
Prescriptions for testosterone nearly doubled in the three years ending in 2013, to 2.3 million, according to the FDA. That drove sales of topical testosterone drugs like AndroGel and Axiron $2 billion a year, with AbbVie taking more than 65% of the market, according to market researcher IMS Health. But the FDA reports that a quarter of the men who received testosterone prescriptions never even had their hormone levels tested.
AbbVie's educational materials "encourage men to talk with their physician, who should take a complete medical history into consideration, conduct a thorough medical exam, and, if necessary, determine the most appropriate treatment option," the company says in its statement.
Still, one big question hangs over this controversy: Does testosterone offer any benefits at all to otherwise healthy aging men? Scientific studies designed to answer that question are notably few in number. Meanwhile, the evidence showing that men can combat the symptoms of aging without testosterone (or any other drug, for that matter) continues to rise. On March 23, scientists at Cedars-Sinai Medical Center in Los Angeles published a study linking exercise to improved sexual function in a racially diverse group of 300 people. In short, men of any ethnicity who exercised frequently reported higher sexual function than those who rarely got off the couch. And the required exercise wasn’t that taxing: Two hours per week of strenuous activities such as running or walking sufficed. Six hours per week or light exercise or 3.5 hours of moderate exercise also worked.
In their journal article, Perls and Handelsman compare the prescribing of testosterone to normal aging guys with an earlier phenomenon involving human growth hormone (HGH). The FDA has only approved HGH to treat children with growth disorders and adults with three rare diseases, but off-label prescribing for anti-aging and bodybuilding was believed to have driven annual sales up 69% to $1.1 billion between 2005 and 2011, according to the authors.
The difference with testosterone is those pervasive direct-to-consumer (DTC) ads. Print and TV advertising for AndroGel, for example, began shortly after its inventor, Solvay Pharmaceuticals, won FDA approval for the product in 2000. AbbVie bought Solvay for $7 billion in 2009 and kept up the aggressive marketing push. The company spent $75.6 million on DTC marketing for AndroGel in 2012, and $67.9 million in 2013, according to data from market-researcher Kantar Media.
Testosterone makers did pull back on their marketing efforts last year, as the FDA’s investigation into potential heart risks was in full swing. Combined testosterone ad spending by Lilly and AbbVie fell from $151.9 million in 2013 to $75 million in 2014, according to Kantar.
That's still too much advertising, Perls contends. “The permissive guidelines [for prescribing testosterone] offered a ticket for drugmakers to just go full-bore with advertising campaigns,” Perls says. In addition to an advertising ban, he says, “I would like to see us revert back to requiring real measurements and careful investigations to determine causes of low testosterone. The cause can’t be aging.”
